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Provalis - a little acorn (PRO)     

pachandl - 23 Jun 2004 16:20

graph.php?epic=PROgraph.php?modeMA=Simple&enableMA=true&ep
Provalis PLC
17 June 2004

For Immediate Release 17th June 2004

Provalis Files G5 Diabetes Test with FDA and builds USA Sales Team

Provalis plc (LSE: PRO; NASDAQ: PVLS), the Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce that, on schedule, it has filed
the USA regulatory submission with the FDA for its G5 diabetes glycated
haemoglobin test.

Regulatory clearances are being sought in the USA for 510K and prescription home
use marketing approvals, which additionally confers CLIA waiver. These allow
the Company to fully exploit the sales potential of G5 into all physicians'
offices and also to be available eventually to diabetics for use at home.

In further preparation for the launch of the product in the USA, Provalis has
now appointed its three vice-presidents of sales to cover the central, west
coast and east coast regions. They, together with Bert Valada the General
Manager of Provalis Diagnostics (USA), have collectively over 100 years of
diagnostics sales experience in the USA and are now building the network of
national sub-distributors ready for product launch in the autumn (fall) of this
year.

Phil Gould, Chief Executive Officer of Provalis said 'We are delighted with the
high quality of the clinical data we have generated with G5 and that we have now
filed on schedule the USA regulatory submission with the FDA. With an
experienced sales team now recruited in the USA, we look forward to a successful
product launch in the autumn of this year'.

END

Provalis' Internet Website ;
http://www.provalis.com


Comment - Provalis has a market cap of 17m. At one time, when called Cortecs, the company was a medium sized pharma. During the tech bubble it lost its way and eventually had to re-invent itself. It re-directed its efforts to the diagnostic side of the market, finally producing Glycosal, a physician's office blood-testing equipment for diabetics. Another rights' issue later and it has finally filed for G5 approval (allowing for a similar test for home use). It has decided to create its own market distribution network - very risky. It is against some much larger competitors such as Axis-Shield (Afinion) which are closer to marketing their own versions of G5 - even offering multi-platform testing - but in less than 90 days Pro will also be selling its G5 product. Diabetes is a huge market, as we all know from reading about obesity etc. Pro only has to catch a small slice of this market to increase its market cap many times over. A very risky punt but it could be rewarding if you get in at the bottom. 7.125p mid-price at the time of writing.

pachandl - 25 Feb 2005 09:43 - 30 of 75

The market does not seem to have reacted favoyrably to this announcement - although the saving of money will almost certainly avioid any further need for a cash-call (IMHO).

LONDON (AFX) - Provalis PLC said it intends to terminate its listing on NASDAQ.

As soon as possible thereafter, it said it will suspend its registration and reporting obligations to the United States Securities and Exchange Commission (SEC).

Provalis said a review of its secondary listing on NASDAQ concluded that the significant costs and management time necessary to comply with additional requirements introduced by recent changes in United States securities laws far outweighed the benefits of the listing.

This action, which is expected to save the group some 700,000 usd between now and June 30 2006 and at least 400,000 usd in each year thereafter, should not cost more than 50,000 usd.

newsdesk@afxnews.com

pachandl - 01 Mar 2005 08:00 - 31 of 75

Highlights of interims - reasonable progress seems to be the order of the day.

For Immediate Release 1st March 2005


Provalis plc

Interim Results for the six months ended 31 December 2004

Provalis plc (LSE: PRO; NASDAQ: PVLS), the International Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce its interim results for the six
months ended 31 December 2004.

Highlights

Group

Group sales 6.7m (1H2004: 6.4m) with gross profit 3.5m (1H2004: 3.6m)
Group operating loss of 2.7m (1H2004: 1.8m) principally reflecting
additional costs of the US sales operation
Group loss for the period of 1.7m; (1H2004: 2.0m)
Share placing in September raised 2.5m net to support manufacture of
in2it(TM)
Closing cash of 1.1m augmented by the scheduled receipt of 2.0m from
Dr Falk Pharma in January
5.0m three year credit facility arranged with Bank of Scotland in
February 2005
Completion of payments to Pfizer for Diclomax
Option for vaccine license agreement granted to Aventis Pasteur

Medical Diagnostics

US FDA 510K clearance and CLIA waiver of in2it(TM) A1c
US sales management team generating significant demand and orders for
in2it(TM) A1c
First shipment of in2it(TM) A1c to the US made in December 2004
Continuing strong demand for in2it(TM) from US market with shipments steadily
increasing from February
Major interest in in2it(TM) from international markets with European launch
expected by autumn 2005
Project for major increase in cartridge manufacturing capacity for in2it(TM)
on course for completion by July 2005
Further tests for the in2it(TM) platform in development

Pharmaceuticals

Sales of 6.1m (1H2004: 5.8m) with net profitability of 0.8m (1H2004; 1.0m)
Diclomax(R) continued to sell well (2.8m) but market remains turbulent
following Merck withdrawal of Vioxx in October 2004 and increased generic
activity
Sales of Dr Falk products at 2.5m; marketing and distribution of these
products ceased in December 2004 and final compensation payment received by
Provalis in January
Erdotin(TM) continues to progress through regulatory process towards UK and
Irish approvals

Phil Gould, Chief Executive Officer of Provalis plc, commented: 'The first half
of the year saw Provalis achieve most of the key strategic objectives necessary
to provide the platform for significant sales growth in the next financial year.
Most importantly, our US sales team generated strong and continuing demand for
in2it(TM) A1c following the grant of regulatory approvals in August.

Demand for in2it(TM) A1c continues to exceed our manufacturing capacity for test
cartridges. The project to deliver a several fold increase in capacity is well
advanced and should be completed by early in the next financial year. This would
allow sales of in2it(TM) A1c to accelerate markedly and, despite the challenges
facing our Pharmaceuticals business, rapidly move the Group as a whole towards
profitability.'


END

pachandl - 02 Mar 2005 18:19 - 32 of 75

It's about time the directors started reaching into their pockets!

Provalis chief exec, finance director buy shares
AFX


LONDON (AFX) - Provalis PLC said chief executive Phil Gould, finance director Peter Bream and director FA Harding have each acquired 100,000 ordinary shares in the company at 5.75 pence each.

Gould now holds 450,689 shares, representing 0.12 pct. Bream now holds 221,462 shares, representing 0.06 pct, and Harding now holds 366,058 shares, representing 0.1 pct.

newsdesk@afxnews.com

slm/

pachandl - 04 Mar 2005 19:38 - 33 of 75

Inv Chr has Pro as "fairly priced" with loss of Dr Falk products and increased generic competition for Diclomax squeezing profits, but counter-balanced by demand for in2it exceeding supply. Probably a faiur assessment at present until increased capacity comes on stream.

jadedhills - 07 May 2005 21:14 - 34 of 75

see what happens in 2months

pachandl - 08 May 2005 13:21 - 35 of 75

Jaded - I think most of us are waiting for a July update on progress towards increasing manufacturing capacity and current level of damand for in2it in the USA. If the rns is positive then we will start moving up towards the 10p mark quite quickly.

pachandl - 26 Jul 2005 09:29 - 36 of 75

At last some good news to halt the downward trend in the sp. I would hope that we can start recovering lost ground and move back towards an sp in the 7-8 range within the next couple of months:

Provalis PLC
26 July 2005



Provalis plc


Update on progress of in2it(TM) A1c


Provalis plc (LSE: PRO; NASDAQ: PVLS), the international medical diagnostics and
pharmaceuticals group, is today providing an update on the progress of its
flagship product for the diabetes market, in2it(TM) A1c.


Shipments of the enhanced in2it(TM) A1c cartridge have now commenced to the USA,
as envisaged in Provalis' June statement. The upgraded analyzer was already in
production and all existing distributors are being restocked with both the
upgraded analyzer and cartridges. In addition, the next phase of the planned
expansion of the cartridge manufacturing capacity is now available, on schedule,
to meet expected demand through the rest of this year and into 2006. Supplies
will build steadily over the next few months and will utilise this increased
cartridge manufacturing capacity.


Phil Gould, Chief Executive Officer of Provalis said,


'We have rapidly made the small design changes to the cartridge manufacturing
process and have already started to ship the enhanced product to the USA.
Demand remains strong for a cost-effective and easy-to-use glycated haemoglobin
testing product for diabetes, given over 17 million Americans are directly
affected.'



26 July 2005



For further information:-


Provalis plc
Dr Phil Gould, Chief Executive Officer 01244 833463
Peter Bream, Finance Director 01244 833552

College Hill
Adrian Duffield/Corinna Dorward, 020 7457 2815/2803

pachandl - 03 Aug 2005 09:41 - 37 of 75

Further positive newsflow - let's hope they can convert this into sales.

Provalis says in2it diabetes diagnostic product gets NGSP certification
AFX


LONDON (AFX) - Provalis PLC said in2it A1c, its flagship diabetes diagnostic product, has been certified by the National Glycohaemoglobin Standardisation Program (NGSP).

NGSP is an independent quality assessment run by the University of Missouri. Provalis said the importance of the certification is such that the American Diabetes Association only recommends, and many health care providers in the USA will only use, tests that are NGSP certified.

Provalis also said its brand building awareness drive in 2005 has won first place in the recent Bio-medical Marketing Association Awards in the category of Product Brand Creation.



newsdesk@afxnews.com

slm/

pachandl - 05 Aug 2005 09:41 - 38 of 75

This is starting to look interesting although I am assuming that the sudden rise today is suggesting that some other positive news is in the "wind":

UK small cap opening - Provalis continues to rise on NGSP certification
AFX


LONDON (AFX) - Shares in Provalis continued to gain after this week's announcement that its flagship diabetes diagnostic product in2it A1c has been certified by the National Glycohaemoglobin Standardisation Program.

At 8.07 am, the shares were trading at 6.37 pence, up 1.12.

AND

Thu 22:29 Wall Street - European ADRs Provalis soars 184% on product news; Total falls AFX UK Focus
LOS ANGELES (AFX) - Shares of U.K. medical diagnostics and pharmaceutical group Provalis surged nearly 200% on positive news for its diabetes diagnostic product on Thursday among U.S.-shares of European companies.

The Bank of New York Europe American Depositary Receipt Index closed down 0.89 point to 130.19, while the overall Composite Index lost 0.88 point to 126.02.

Earlier, banking stocks weighed on European markets. Germany's DAX 30 index closed down 1%, France's CAC 40 index fell 0.8% and the U.K.'s FTSE 100 index slipped 0.3%.

Provalis jumped $5.51, or 184.3%, to $8.50 after the company said its flagship diabetes diagnostic product, in2it(TM)A1c, has been certified by the National Glycohaemoglobin Standardization Program (NGSP).

NGSP is an independent quality assessment run by the University of Missouri.



robstuff - 05 Aug 2005 10:40 - 39 of 75

pachandl - can you explain to me if you know, why there is a different listing of the shares in the US at $8.50 and why they should have risen so much over there? Cheers.

carrins - 07 Aug 2005 14:41 - 40 of 75

PRO investors,this company's SP is flying and to-morrow it will start to rocket because it has simply a very good product which in my opinion will sell like cheese cakes.

pachandl - 07 Aug 2005 15:28 - 41 of 75

Rob - Shares in US are traded as ADRs and probably worth about 30 times the value of each UK share. A while back Pro said they would be delisting from US because of the exceptionally expensive accountancy practices. Hope that helps.

pachandl - 08 Aug 2005 13:19 - 42 of 75

Robstuff- for you - copied from adv BB - I am sure rmart will not be unduly upset :


rmart - 8 Aug'05 - 11:35 - 4327 of 4342

Provalis may suspend its SEC registration and reporting obligations if the
number of US residents who hold Provalis securities (either ADRs on NASDAQ or
ordinary shares on the London Stock Exchange), directly or through nominees,
falls below 300.


In order to reduce the number of US residents holding Provalis securities to
less than 300, Provalis intends to implement the following as soon as possible:


* Give written notice of termination of Provalis' ADR
programme, effective in 90 days;

* Upon the termination of the programme at the end of this 90-day
notice period, no further transfers of ADRs will be permitted and
trading of ADRs on NASDAQ will cease; as a consequence, there will be no
liquid trading market for the sale or purchase of Provalis ADRs;

* Holders of any ADRs which remained outstanding would then have
2 months in which to surrender their ADRs in return for Provalis ordinary
shares, subject to payment by the holder of a cancellation fee;

* Any ADR holders that surrender their ADRs in return for
Provalis ordinary shares would subsequently hold and trade the ordinary shares
on the London Stock Exchange; and

* On the expiry of this 2 month period, the ordinary shares underlying any
remaining outstanding ADRs would be sold by the Bank of New York
(the provider of Provalis' ADR programme) on the open market, with the sale
proceeds distributed to the ADR holders in cash.


bharathi_raj - 08 Aug 2005 14:16 - 43 of 75

So - buys outstrip sells 2 to 1 and the price drops!
The brokers are playing a sucker punch = drop the price - shake the tree - watch the suckers fall out - then motor the price up - buy the stock cheap and drive the price up to sell expensive

If you have this stock keep it! Don't let the brokers con you.

bharathi_raj - 10 Aug 2005 09:12 - 44 of 75

Why the drop today - is there any news out there?

700202 - 10 Aug 2005 09:15 - 45 of 75

hi bharathi raj WELL DONE I THINK YOUR EXACTLY RIGHT,WITH DIABETES GETTING A BIGGER AND BIGGER PROBLEM THE SP SHOULD BE FLYING,THIS IS A GREAT TIME TO BUY BUY BUY,WATCH THIS BY XMAS CAN SEE IT AT 12/15 I AM HOLDING 300K @ 7.4 I AM NOT SELLING.

700202 - 10 Aug 2005 09:19 - 46 of 75

BHARATHI RAJ TREE SHAKING BY THE MARKET MAKERS,I AM GOING IN AGAIN.

pachandl - 10 Aug 2005 09:53 - 47 of 75

Finally Gould departs the scene. A very good technician but has failed to capitalise on Pro's lead in the diabetes testing market. Good news on the whole I feel.

700202 - 10 Aug 2005 10:08 - 48 of 75

YEE OF LITTLE FAITH BACK IN @6.25 100K I AGREE WITH PACHANDI THIS WILL BE STRONG WITH PETER WOODFORD ON BOARD

bharathi_raj - 18 Aug 2005 12:28 - 49 of 75

why all sells today - do we have some news out there?
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